Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized durvalumab in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by durvalumab as monotherapy as adjuvant treatment, for the treatment of adult patients with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence and no EGFR mutations or ALK rearrangements. This indication is based on AEGEAN (NCT03800134), a randomized, double-blind, placebo-controlled, multicenter trial where the choice of platinum-containing chemotherapy was dependent on tumor histology. Specifically, patients with squamous tumor histology received either carboplatin with paclitaxel or cisplatin with gemcitabine, and patients with non-squamous tumor histology received either pemetrexed with carboplatin or pemetrexed with cisplatin.

This is written in the approval document as:

IMFINZI in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy as adjuvant treatment, is indicated for the treatment of adults with resectable NSCLC at high risk of recurrence and no EGFR mutations or ALK rearrangements.

Citation

AstraZeneca AB. Imfinzi (durvalumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf. Revised July 2025. Accessed August 29, 2025.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Carboplatin, Durvalumab, Paclitaxel
Sensitivity (+)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Cisplatin, Durvalumab, Gemcitabine
Sensitivity (+)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Cisplatin, Durvalumab, Pemetrexed
Sensitivity (+)	Wild type ALK, Wild type EGFR	Non-Small Cell Lung Cancer	Carboplatin, Durvalumab, Pemetrexed